Approach to Ankle Sprains in the Emergency Department

Evaluation of Analgesic Treatments for Ankle Sprains in the Emergency Department

The aim of this study is to evaluate the short-term effects of routinely applied agents on pain and joint range of motion (ROM) in ankle sprains presenting to the emergency department (ED).

Study Overview

• Status: Completed
• Conditions: Ankle Sprains
• Intervention / Treatment: Drug: Dexketoprofen Trometamol 50 Mg/mL Solution for Injection; Drug: isotonic saline; Drug: Ibuprofen 100 MG/ML Solution for Injection; Drug: Paracetamol 10 Mg/mL Solution for Injection

Detailed Description

It is aimed to examine the effects of intravenous (IV) 50 mg dexketoprofen, IV ibuprofen 400mg and IV paracetamol 10 mg on pain and joint range of motion. To determine the effects of these agents on pain, the easily applicable Numerical Rating Scale (NRS) and Wong-Baker Faces Pain Rating Scale will be used. A standard handheld half-circle goniometer will be utilized to calculate active ankle joint ROM.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Yenimahalle
    • Ankara, Yenimahalle, Turkey, 38000
      • Ankara Etlik City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adults aged 18 years and older who present to the emergency department within the first 72 hours after ankle sprain.
• Grade 1 (mild) and Grade 2 (moderate) ankle sprains.
• Exclusion of fractures and dislocations (after X-ray according to Ottawa rules).
• Absence of muscle-tendon ruptures.
• Absence of vascular and nerve injuries.
• Absence of open wounds and burns.
• Stable vital signs.
• Patients who provide written and verbal consent.

Exclusion Criteria:

• Patients who did not present to the emergency department within the first 72 hours after ankle sprain.
• Grade 3 (severe) ankle sprains.
• Multiple traumas.
• Pregnancy or suspected pregnancy.
• Ankle fractures and dislocations.
• Forensic cases.
• History of previous ankle surgery or fracture.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group Dexketoprofen; Dexketoprofen 50 mg will be administered parenterally (intravenously in 150 cc isotonic saline over 15 minutes infusion).	Drug: Dexketoprofen Trometamol 50 Mg/mL Solution for Injection; Dexketoprofen 50 mg administered parenterally (intravenously in 150 cc isotonic saline over 15 minutes infusion).; Drug: isotonic saline; Ibuprofen and dexketoprofen will be administered intravenously (IV) by mixing them into 150 cc of isotonic saline.
Active Comparator: Group Ibuprofen; Ibuprofen 100 mg/ml will be administered parenterally (intravenously in 150 cc isotonic saline over 15 minutes infusion).	Drug: isotonic saline; Ibuprofen and dexketoprofen will be administered intravenously (IV) by mixing them into 150 cc of isotonic saline.; Drug: Ibuprofen 100 MG/ML Solution for Injection; Ibuprofen 100 mg/ml administered parenterally (intravenously in 150 cc isotonic saline over 15 minutes infusion). Group P: Paracetamol 10 mg/ml administered parenterally (intravenously in 150 cc isotonic saline over 15 minutes infusion).
Active Comparator: Group Paracetamol; Paracetamol 10 mg/ml will be administered parenterally.	Drug: Paracetamol 10 Mg/mL Solution for Injection; Paracetamol 10 mg/ml administered parenterally (intravenously in 150 cc isotonic saline over 15 minutes infusion).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the effectiveness of multimodal treatment methods on pain in ankle sprains.	Numeric Rang Scale (NRS) will be used to assess effects on pain. NRS: This scale uses 11 numbers from 0 to 10 to measure pain intensity, where 0 represents "No pain" and 10 represents "Worst (unbearable) pain."	*Patient's pain level, NRS Scale: - 0 minute before treatment -15 minute after treatment -60 minute after treatment
To evaluate the effectiveness of multimodal treatment methods on pain in ankle sprains.	Wong-Baker FACES pain rating scale (WBS) will be used to assess effects on pain. WBS: This scale uses a series of faces ranging from a smiling face representing "No pain" to a crying face representing "Worst pain" to visually express the intensity of pain.	*Wong-Baker Faces Pain Rating Scale: - 0 minute before treatment -15 minute after treatment -60 minute after treatment
To evaluate the effectiveness of multimodal treatment methods on Range of Motion in ankle sprains.	A standard handheld goniometer will be used to calculate Range of Motion (ROM) measurements. The aim is to determine the effects of multimodal treatment methods routinely applied in emergency services on pain and range of motion and to reveal their superiority over each other, if any. (Normal ROM values: 20° for dorsiflexion, 45° for plantar flexion)	- 0 minute ROM before treatment - 60 minute ROM after treatment

Collaborators and Investigators

• Sponsor: Ankara Etlik City Hospital
• Investigators: Study Director: Ahmet B. Erdem, Ankara Etlik City Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Actual): May 1, 2024
• Study Completion (Actual): June 1, 2024

Study Registration Dates

• First Submitted: July 8, 2024
• First Submitted That Met QC Criteria: August 19, 2024
• First Posted (Actual): August 20, 2024

Study Record Updates

• Last Update Posted (Actual): August 20, 2024
• Last Update Submitted That Met QC Criteria: August 19, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Range of motion; Numerical Rating Scale
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Sprains and Strains; Ankle Injuries; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Acetaminophen; Pharmaceutical Solutions; Ibuprofen; Dexketoprofen trometamol
• Other Study ID Numbers: ES-Ankle

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No